Executive Summary - Clinical Review Report: Tocilizumab (Actemra) - NCBI Bookshelf.Actemra Cuts Steroid Needs Even in Nonresponders

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- Rheumatoid Arthritis Patients with Low Disease Activity on Actemra May Taper Off Prednisone

Inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency. We're building a better ClinicalTrials.

Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Tocilizumab Plus a Short Prednisone Taper for GCA The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Listing a study does not mean it has been evaluated by the U. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Last Update Posted : July 26, See Contacts and Locations. View this study on Beta. Study Description. This is an open-label pilot study of tocilizumab TCZ mg weekly administered subcutaneously for 52 weeks in combination with 8 weeks of oral prednisone.

The contents of this website are for informational purposes only and do not constitute medical advice. Always seek the advice of a physician or other qualified health provider with any questions you may have regarding a medical condition. All rights reserved.

Part of the Global Healthy Living Foundation, a c 3 non-profit organization. Reservados todos los derechos. Login to comment on posts, connect with other members, access special offers and view exclusive content. Username or E-mail. Keep me signed in. Forgot your password? The available evidence was limited to a single RCT with a relatively small number of patients per treatment group and treatment duration of 52 weeks. Missing doses during the taper were assumed to be the minimum-dose tablets from that pack.

Patients who received an increased dose of prednisone because they entered escape therapy were included in their originally assigned treatment group.

There was no imputation of missing data. Source: Clinical Study Report. This information is based on information provided in draft form by the clinical expert consulted by CDR reviewers for the purpose of this review.

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Help Accessibility Careers. Search term. Executive Summary. Introduction Giant cell arteritis GCA is a systemic large-vessel vasculitis found almost exclusively in patients aged 50 years and older. Potential Place in Therapy a According to the clinical expert consulted for this review, the first objective of the treatment of GCA is to control the signs and symptoms of the disease and to prevent complications such as visual loss and stroke.

Conclusions One trial, which evaluated the use of tocilizumab SC versus placebo in patients with active GCA , met the inclusion criteria for the systematic review. Infections were the most frequently reported adverse event in all treatment groups. In this Page. Introduction Results and Interpretation. Other titles in this collection. Recent Activity. Clear Turn Off Turn On. Follow NCBI. Tocilizumab Actemra. For the treatment of giant cell arteritis GCA in adult patients. As per indication.

Tocilizumab doses of mg administered via subcutaneous injection weekly plus week prednisone tapering. October 27, Hoffmann-La Roche Limited.

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Actemra and prednisone. Actemra Cuts Steroid Needs Even in Nonresponders

A dedicated register of all Canadian patients treated with tocilizumab would be invaluable in answering important aspects of safety. Forgot your password?

By week 24, Corticosteroids were withdrawn completely in one patient at week four, three patients at week eight, eight patients at week 12, and 15 patients at week And it is possible that in patients treated with high-dose corticosteroids, the clinician's main objective is to reduce dosage rather than RA activity, the authors noted.

At week 24, there was a nonsignificant trend toward a greater reduction in corticosteroids dose in nonresponders to tocilizumab treatment than responders, with a mean decrease of 6. With initial corticosteroids doses higher in nonresponders, the authors suggested that patients on high initial doses likely had more severe disease that was less amenable to treatment.

Before sharing sensitive information, make sure you're on a federal government site. The site is secure. NCBI Bookshelf. View in own window. Giant cell arteritis GCA is a systemic large-vessel vasculitis found almost exclusively in patients aged 50 years and older. Symptoms typically resolve rapidly in response to corticosteroid therapy and if the patient is free of symptoms and abnormal laboratory parameters, the corticosteroid dose can be tapered gradually over the course of one to two years.

The long-term use of oral corticosteroid therapy introduces a host of adverse effects and increases the risk of bone fractures, worsening of diabetes and hypertension, thrombotic events, gastrointestinal bleeding, muscle weakness from myopathy, glaucoma, and cataracts.

Tocilizumab is an anti-human interleukin-6 IL-6 receptor monoclonal antibody that binds to and inhibits signalling through both soluble and membrane-bound IL-6 receptors. Tocilizumab is also approved in Canada for patients with polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Patients enrolled were either newly diagnosed or had relapsing disease and were receiving treatment with 20 mg to 60 mg of prednisone daily.

Patients were randomized to tocilizumab mg SC weekly or every other week both with a week prednisone taper , placebo with week prednisone taper, or placebo with week prednisone taper. Patients who experienced a disease flare or could not adhere to the taper due to ongoing disease activity stopped the protocol-defined tapering schedule and could receive escape prednisone. A patient could have symptoms of GCA or elevated ESR and still be considered in remission if the investigator determined these symptoms were not severe enough to be classified as a disease flare.

Sustained remission the primary end point was defined as the absence of flare following induction of remission within 12 weeks of randomization and maintained from week 12 up to week The primary outcome analysis compared the proportion of patients in sustained remission at week 52 for each tocilizumab group versus the placebo plus week prednisone taper group. The key secondary outcome assessed noninferiority of each tocilizumab group versus the placebo plus week taper for the proportion of patients in sustained remission.

The GiACTA study was not adequately powered or of sufficient duration to evaluate longer-term GCA - and prednisone-related morbidities such as fractures and cardiovascular events, which are important to patients.

Moreover, the available evidence was limited to a single RCT with a relatively small number of patients per treatment group 50 or For both tocilizumab dosage groups, the lower bound of the Similar results were observed in the analysis of patients who completed the study and were compliant with treatment.

Sensitivity analyses for the primary outcome suggested that the findings were generally robust. These data suggested no notable differences in sustained remission rate with tocilizumab versus placebo for relapsing GCA patients versus new-onset patients, although the data were limited by small sample sizes and no between-group comparisons or treatment-by-disease status interaction P values were reported.

Tags: Rheumatoid Arthritis. CreakyJoints is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research.

Tocilizumab is an interleukin-6 IL-6 receptor inhibitor. Outcome Measures. Primary Outcome Measures : Sustained remission [ Time Frame: 52 weeks ] Proportion of patients in sustained remission by week Number, nature and severity of adverse events by week Number and nature of serious adverse events by week Eligibility Criteria.

Information from the National Library of Medicine Choosing to participate in a study is an important personal decision. Patients on methotrexate at screening will require discontinuation of this agent prior to baseline visit.

Patients should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment. Patients treated for LTBI within 3 years are eligible. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials. More Information.

Study record managers: refer to the Data Element Definitions if submitting registration or results information. This is a single center, open label study that will assess the efficacy and safety of 52 weeks of tocilizumab TCZ in combination with 8-weeks of prednisone in 30 patients with active giant cell arteritis GCA.

The primary endpoint of the study, sustained remission, will be assessed at week The definition of sustained remission contains 3 elements:. Prednisone taper over 8 weeks with a starting dose between 20 and 60 mg. Talk with your doctor and family members or friends about deciding to join a study.

To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies. Diagnosis of GCA classified per the following criteria:. Inability, in the opinion of the investigator, to withdraw GC treatment through protocol-defined taper regimen due to suspected or established adrenal insufficiency.

We're building a better ClinicalTrials. Check it out and tell us what you think! Hide glossary Glossary Study record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms. Save this study. Warning You have reached the maximum number of saved studies Tocilizumab Plus a Short Prednisone Taper for GCA The safety and scientific validity of this study is the responsibility of the study sponsor and investigators.

Detailed Description:. Completion of the pre-specified prednisone taper protocol Absence of disease flare relapse since the induction of remission by week 8. Drug Information available for: Prednisone Tocilizumab. FDA Resources. Arms and Interventions. Tocilizumab is an interleukin-6 IL-6 receptor inhibitor.

Outcome Measures. Primary Outcome Measures : Sustained remission [ Time Frame: 52 weeks ] Proportion of patients in sustained remission by week Number, nature and severity of adverse events by week Number and nature of serious adverse events by week Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Patients on methotrexate at screening will require discontinuation of this agent prior to baseline visit. Patients should be screened for latent TB and, if positive, treated according to local practice guidelines prior to initiating TCZ treatment. Patients treated for LTBI within 3 years are eligible. Contacts and Locations.

Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.

More Information. GCA Tocilizumab Prednisone. National Library of Medicine U. National Institutes of Health U. Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Giant Cell Arteritis. Drug: Tocilizumab Drug: Prednisone. Phase 4. Study Type :. Interventional Clinical Trial. Estimated Enrollment :. Actual Study Start Date :. Estimated Primary Completion Date :.

Estimated Study Completion Date :. Experimental: Tocilizumab and prednisone TCZ mg administered by subcutaneous injection weekly for 52 weeks. Contact: Ana D Fernandes October 31, Key Record Dates.

Comparing Actemra vs Prednisone ; A total of drugs are known to interact with Actemra: 48 major drug interactions ( brand and generic names); moderate. Tocilizumab plus prednisone was linked to a sixfold reduced risk for linked with failure to respond to tocilizumab (Actemra, Genentech). Tocilizumab plus prednisone was linked to a sixfold reduced risk for linked with failure to respond to tocilizumab (Actemra, Genentech). Treatment options for GCA are limited and guidelines state that therapy with prednisone or prednisolone should be initiated immediately upon suspicion of. Tocilizumab (Actemra) may have positive effects in patients not showing clinical responses by allowing reductions in corticosteroids doses, according to a. Sensitivity analyses for the primary outcome suggested that the findings were generally robust. NCBI Bookshelf.

Barbara Brody. People with moderate-to-severe rheumatoid arthritis RA often need to take a biologic drug as well as a glucocorticoid in order to get their disease activity under control. Can people with RA taking the biologic drug tocilizumab Actemra and the glucocorticoid prednisone safely ditch the prednisone once they meet the criteria for low disease activity?

The study, a randomized, controlled trial, followed patients who had reached remission or low disease activity while taking a combination of Actemra and prednisone.

Over the course of 24 weeks, one group of patients continued both drugs while the other slowly tapered off prednisone until they were no longer using it. The authors concluded that sticking with prednisone provided better disease activity control compared to tapering off it, but that the overall difference in disease activity scores DASESR in both the taper and non-taper groups was similar. All drugs, including Actemra — an interleukin 6 IL-6 inhibitor — have side effects, but patients tend to especially dislike taking gluticorticoids like prednisone.

Glucocorticoids are a type of steroid medication, and they often cause bothersome side effects including weight gain, acne, dizziness, and insomnia, as well as raise the risk of longer-term health problems like osteoporosis and diabetes. Tags: Rheumatoid Arthritis. CreakyJoints is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research.

We present patients through our popular social media channels, our website CreakyJoints. We represent patients through our popular social media channels, our website CreakyJoints. Only fill in if you are not human. EULAR Share Facebook Twitter Email. Rheumatoid Arthritis. Subscribe to CreakyJoints for more related content. About CreakyJoints CreakyJoints is a digital community for millions of arthritis patients and caregivers worldwide who seek education, support, advocacy, and patient-centered research.

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